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Journal of the Formosan Medical Association (2014) xx, 1e8

Available online at www.sciencedirect.com

ScienceDirect journal homepage: www.jfma-online.com

ORIGINAL ARTICLE

Assessing quality of life in Taiwanese patients with Graves’ ophthalmopathy I-Chan Lin a, Chih-Chao Lee b, Shu-Lang Liao c,* a

Department of Ophthalmology, Shuang-Ho Hospital, Taipei Medical University, Taipei, Taiwan Department of Ophthalmology, Chi-Mei Hospital, Tainan, Taiwan c Department of Ophthalmology, National Taiwan University Hospital, School of Medicine, Taipei, Taiwan b

Received 25 June 2013; received in revised form 8 November 2013; accepted 9 December 2013

KEYWORDS Graves’ ophthalmopathy; quality of life; questionnaire

Background/Purpose: This study investigated the clinical significance of quality of life (QOL) related specifically to Graves’ ophthalmopathy (GO) among Taiwanese patients. Methods: We recruited 271 patients with GO who were seen at the National Taiwan University Hospital Department of Ophthalmology from September 1, 2012 to November 30, 2012. Patients completed the GO-QOL Questionnaire. The main outcome measures were the scores on two GO-QOL subscales: visual functioning and appearance. The percentage of responses occurring at the maximum and minimum values was also calculated to assess possible ceiling and floor effects, respectively. Results: The mean  standard deviation QOL scores for the subscales of visual functioning and appearance were 58.39  25.17 and 54.45  20.52, respectively. The scores for both subscales were significantly correlated with disease severity and clinical activity scores (all p < 0.05). The QOL scores for the appearance subscale were significantly correlated with the degree of diplopia (p < 0.05). No significant ceiling or floor effects were observed for either subscale of the GO-QOL. Conclusion: Scores on the Chinese (Taiwan) version of the GO-QOL were strongly correlated with disease severity and clinical activity. The GO-QOL is a simple and practical tool that can be used to evaluate health-related QOL in GO patients. Copyright ª 2014, Elsevier Taiwan LLC & Formosan Medical Association. All rights reserved.

Conflicts of interest: All contributing authors declare no conflicts of interest. * Corresponding author. Department of Ophthalmology, National Taiwan University Hospital, 7 Chung-Shan South Road, Taipei 100, Taiwan. E-mail address: [email protected] (S.-L. Liao). 0929-6646/$ - see front matter Copyright ª 2014, Elsevier Taiwan LLC & Formosan Medical Association. All rights reserved. http://dx.doi.org/10.1016/j.jfma.2013.12.002

Please cite this article in press as: Lin I-C, et al., Assessing quality of life in Taiwanese patients with Graves’ ophthalmopathy, Journal of the Formosan Medical Association (2014), http://dx.doi.org/10.1016/j.jfma.2013.12.002

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Introduction Graves’ ophthalmopathy (GO) is a chronic, debilitating infiltrative eye disease that is often associated with Graves’ disease or occasionally with Hashimoto’s thyroiditis. Approximately 50% of patients with Graves’ disease develop GO, and those patients often suffer from ocular pain, changed appearance, and impaired visual function.1 The severity of GO can be quantified using various clinical measures, including tests of optic nerve function or measurements of proptosis and strabismus. However, these clinical parameters fail to quantify several of the most troublesome features of GO, such as altered appearance and ocular pain symptoms. The GO-Quality of Life Questionnaire (GO-QOL), created by Terwee et al,2 was the first instrument designed specifically to measure health-related QOL in patients with GO. The questionnaire consists of 16 questions focusing on two specific consequences of GO-visual impairment: (1) double vision or decreased visual acuity (8 questions); and (2) psychosocial effects of facial disfigurement (8 questions). Scores on the GO-QOL have shown strong correlations with clinical manifestations of GO and with two other health-related QOL questionnaires (Medical Outcome Study 24-item Short Form Health Survey and Sickness Impact Profile).2e5 The GO-QOL was originally developed in Dutch, but has been translated into several languages and used in various countries.6e10 An increasing number of studies have used GO-QOL score as one of several outcome measures to evaluate treatment effects.7,8,11,12 For this study, we translated the GO-specific QOL survey into traditional Chinese and used the questionnaire with a group of GO patients in Taiwan (Appendix 1). The purpose of our study was to assess the QOL of Taiwanese patients with GO and to evaluate the correlations between the severity of the disease and QOL scores.

Materials and methods We downloaded the English version of the GO-QOL from the European Group on Graves’ Orbitopathy (EUGOGO) website13 and translated the GO-QOL into Chinese. The questionnaire was scored as described by Terwee et al.2 This QOL instrument was specifically designed for GO patients and should not be used to assess patients with unrelated health conditions. We recruited patients with GO who were seen at the National Taiwan University Hospital Department of Ophthalmology (Taipei, Taiwan) between September 1, 2012 to November 30, 2012. The study group included 271 consecutive patients with GO. To be eligible for the survey, patients were required to have thyroid function tests with the reference range prior to and within 6 months at the time of completing the survey. Clinical data were obtained retrospectively from the medical records. From the survey, 45 patients (16.6%) had received orbital decompression prior to completing the survey. This study was approved by the National Taiwan University Committee, and informed consent was obtained from all participants.

I.-C. Lin et al. All patients completed the GO-QOL during their outpatient clinic consultation. The majority of the questionnaires were completed without assistance, but explanations of questions were provided by study personnel if requested by a patient. The Chinese GO-QOL contained 16 items focusing on two specific consequences of GO-visual impairment: (1) limitations in carrying out daily activities; and (2) psychosocial consequences related to thyroid eye disease. Each item was scored on a 3-point scale (1 Z severely limited; 2 Z a little limited; 3 Z not limited at all). The responses for Items 1e8 and for Items 9e16 were summed to yield 2 raw scores. The possible values for these scores ranged from 8 to 24. The raw scores were then transformed to 2 scores from 0 to 100 using the following formula: (total scores e #) / (2  #)  100, where # represents the number of completed items. For both scores, 0 indicated the worst possible health state, and 100 indicated the best possible health state. When a participant responded that he or she did not perform an activity for any reason, the response was scored as missing, as described in the GO-QOL scoring algorithm. Patients also received a complete ophthalmic assessment, including proptosis measurement, lid retraction, extraocular muscle involvement, and optic neuropathy. Proptosis was measured by Hertel exophthalmometry. The degree of diplopia was assessed objectively by the Worth four dots test, and subjectively by the Gorman scale, with scores being as follows: Grade 0, no diplopia; Grade 1, intermittent; Grade 2, inconstant (gaze evoked); and Grade 3, constant diplopia in primary gaze or while reading.14 Optic neuropathy was defined as the presence of disc swelling or pallor, plus any one of the following: (1) a visual field defect detected by Humphrey visual field testing, in the absence of other ocular comorbidity for visual field defect; (2) relative afferent papillary defect in the absence of other ocular comorbidity; and (3) Snellen visual acuity < 20/60, in the absence of other reasons for sight loss. Inflammatory activity was represented using the clinical activity score, which is based on seven signs of inflammation of the orbit. Each item was scored as absent (0) or present (1), with a maximum possible score of 7, and total possible scores ranging from 0 to 7. Scores of 0e2 indicated

Table 1 Components of the clinical activity score for Graves’ ophthalmopathy (GO).a       

Spontaneous retrobulbar pain Pain with eye movement Redness of the eyelids Redness of the conjunctiva Swelling of the eyelids Swelling of the caruncle Conjunctival edema (chemosis)

a The clinical activity score is calculated according to the presence or absence of the characteristics listed. The score ranges from 0 to 7, with 0e2 characteristics indicating inactive GO and 3e7 characteristics indicating active GO.

Please cite this article in press as: Lin I-C, et al., Assessing quality of life in Taiwanese patients with Graves’ ophthalmopathy, Journal of the Formosan Medical Association (2014), http://dx.doi.org/10.1016/j.jfma.2013.12.002

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Quality of life in Graves’ ophthalmopathy inactive GO, and scores of 3e7 indicated active GO15 (Table 1). The clinical severity of GO was scored according to the NOSPECS system [no signs or symptoms; only signs; soft tissue involvement (edema of conjunctivae and lids, conjunctival injection); proptosis; extraocular muscle involvement; corneal involvement; sight loss] as recommended by EUGOGO.16 According to a study by Tsai et al,17 the mean Hertel value for exophthalmos was 13.91 mm in a normal Taiwanese population. We thus selected 14 mm as the Hertel value for normal exophthalmos. The severity of soft tissue involvement was scored using a modified EUGOGO case record form and the Color Atlas.16 Mild GO was defined as any one of the following: minor lid retraction (30% of respondents attaining the maximum possible value for each subscale. Similarly, significant and substantial floor effects were defined as >15% and >30%, respectively, of responses falling at the minimum value for a subscale.19 We accepted this definition in our study because the conditions studied by Bradley et al19 appeared similar to ours. The statistical analyses were conducted using R 2.11.1 software (R Foundation for Statistical Computing, Vienna, Austria). Multiple logistic regression and linear regression were used to analyze the relationship between independent and dependent variables. Independent variables were factors influencing the GO-QOL score, such as disease severity or activity, and the dependent variables were the two GO-QOL subscale scores, appearance and visual functioning. Analyses were performed to assess which of the

3 independent variables were or were not related to the dependent variables. Basic model-fitting techniques for regression analysis were applied to ensure the quality of the analysis results. In the stepwise variable selection procedure, both significance level for entry and significance level for stay were set to 0.15. The coefficient of determination (R2) represents the square of the Pearson correlation coefficient for the observed versus predicted value of a continuous response variable in a linear regression model. A larger value of R2 indicates a better fit of the linear regression model. The “percentage of concordant pairs” is the percentage of the “concordant” pairs, in which the observation with the event (i.e., the observed binary response is 1) has the higher predicted event probability, among the total number of the pairs of observations with different response values (e.g., 0 vs. 1). It has a value between 0% and 100% with a larger value indicating a better fit of the logistic regression model to the observed binary data. For all statistical analyses in this study, a two-sided p  0.05 was considered statistically significant. Covariates with borderline significant p values would still be included in the final fitted multiple linear or logistic regression models.

Results Demographic data for all patients are shown in Table 2. Most of our patients were women, and more than half had a mild severity of GO. Nearly a quarter of the patient experienced diplopia. The frequencies of responses to each item of GO-QOL are summarized in Table 3. All patients who were given the GO-QOL completed it (100% response rate). The most frequently limited activities were reading (81.9%), doing something they wanted to do (87.1%), doing hobbies or pastimes (68.2%), watching television (63.5%),

Table 2 Demographics and clinical characteristics of Graves’ ophthalmopathy (GO) patients (n Z 271). Female/male Age, median (range), y Clinical severity Mild Moderate to severe Sight-threatening Diplopia No diplopia Intermittent diplopia Inconstant diplopia Constant diplopia Clinical activity score Inactive GO Active GO Proptosis, median (range), mm

n

%

192/79 42.3 (14e85)

70.8/29.1

148 97 26

54.61 35.62 9.96

202 49 15 5

74.54 18.08 5.54 1.85

217 54 18.2 (12e28)

80.1 19.9

Please cite this article in press as: Lin I-C, et al., Assessing quality of life in Taiwanese patients with Graves’ ophthalmopathy, Journal of the Formosan Medical Association (2014), http://dx.doi.org/10.1016/j.jfma.2013.12.002

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I.-C. Lin et al. Table 3

Frequencies of responses to items on the visual functioning subscale and appearance subscale (n Z 271).

Limitations in carrying out the following activities

Severely limited

Mildly limited

Not limited

Missing response

1. 2. 3. 4. 5. 6. 7. 8.

11.1 15.5 16.6 17.7 22.9 8.1 14.8 17.0

39.9 33.6 26.2 45.0 59.0 55.4 53.4 70.1

31.7 28.4 57.2 37.3 18.1 36.5 32.8 12.9

17.3a 22.5a 0.0 0.0 0.0 0.0 0.0 0.0

Psychosocial consequences because of thyroid eye disease

Very much

A little

No

Missing response

1. 2. 3. 4. 5. 6. 7. 8.

45.0 35.4 25.5 32.5 4.1 3.7 29.2 14.8

46.5 56.5 31.4 42.8 31.0 63.5 52.8 43.2

8.5 8.1 43.2 24.7 64.9 32.8 18.1 42.1

0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0

Bicycling Driving Moving around the house Walking outdoors Reading Watching TV Hobbies or pastimes Hindered from doing something you wanted to do

Appearance has changed Stared at in the streets People react unpleasantly Influence on self-confidence Socially isolated Influence on making friends Appear less often in photos than before Mask changes in your appearance

Data are presented as %. a “Never learned to ride a bike” and “no driver’s license” were scored as missing responses.

Table 4

Results of univariate analysis.

Covariate Gender Male Female Diplopia No diplopia Intermittent diplopia Inconstant diplopia Constant diplopia Severity Mild Moderate to severe Sight-threatening Clinical activity Inactive Active

Visual functioning

P*

Appearance

0.6067 59.27  23.86 57.47  26.53

0.0253 51.9  20.16 57.1  20.63

0.3227a 60.02 53.27 54.59 53.75

   

25.40 24.59 25.14 18.54

59.13 40.18 43.33 38.75

   

61.52  25.17 45.78  21.10

Assessing quality of life in Taiwanese patients with Graves' ophthalmopathy.

This study investigated the clinical significance of quality of life (QOL) related specifically to Graves' ophthalmopathy (GO) among Taiwanese patient...
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